An Evaluation of the FreeStyle Libre Flash Glucose Monitoring System

NCT ID: NCT03071159

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-10

Study Completion Date

2018-03-10

Brief Summary

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Medium-term (6-12 months) evaluation of the use, the identified problems, the usability and the effect on the metabolic control of the FreeStyle Flash Libre glucose monitoring system in 90 children by questionnaires and routine measurement of HbA1c values.

Detailed Description

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Conditions

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Flash Glucose Monitoring Metabolic Control

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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cases

children (4-18 years) with type 1 diabetes mellitis using the FreeStyle Flash Libre glucose monitoring system (standard care)

Group Type OTHER

FreeStyle Flash Libre glucose monitoring system

Intervention Type DEVICE

glucose monitoring system with sensors

Interventions

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FreeStyle Flash Libre glucose monitoring system

glucose monitoring system with sensors

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes mellitis
* Being followed in the Pediatric Diabetes Unit of the Jessa Hospital

Exclusion Criteria

\-
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guy Massa, MD, PhD

Role: STUDY_DIRECTOR

Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500

Locations

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Jessa Hospital

Hasselt, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Guy Massa, MD, PhD

Role: CONTACT

+32 11 30 96 34

Ingrid Arijs, PhD

Role: CONTACT

+32(0)11 33 82 65

Facility Contacts

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Guy Massa, MD, PhD

Role: primary

Other Identifiers

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JessaH

Identifier Type: -

Identifier Source: org_study_id

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